Kornimate/medical-research-clean huggingface dataset:
validation and reliability of the cho-klat in turkish

Conditions: Hemophilia A; Hemophilia B

Summary: the aim of this study is to investigate the turkish validity and reliability of the canadian haemophilia outcomes-kids' life assessment tool version2.0. patients aged 4-18 years with hemophilia a or b will be included in the study. the study was planned as a multicenter and it is aimed to reach 100 patients. the process included four steps: a linguistic adaptation, cognitive debriefing interviews with children and their parents, a validity assessment with the pediatric quality of life inventory (pedsql) as a comparator, and a test retest reliability assessment.

health-related quality of life assessment is considered an important outcome in the evaluation of children with hemophilia. the canadian haemophilia outcomes-kids' life assessment tool version2.0 is a disease-specific health-related quality of life measurement tool for 4 to 18-year-old boys with haemophilia. the aim of this study is to ensure the use of cho-klat in clinical studies in turkey. methods: patients aged 4-18 years with hemophilia a or b will be included in the study.the study will be carried out in van, gaziantep and adana provinces in turkey and and it is aimed to reach 100 patients with hemophilia. the process included four steps: a linguistic adaptation, cognitive debriefing interviews with children and their parents, a validity assessment with the pediatric quality of life inventory (pedsql) as a comparator, and a test retest reliability assessment.

Eligibility criteria:
inclusion criteria: * have hemophilia a or b exclusion criteria: * did not have significant cognitive impairment

Keywords: hemophilia health related quality of life
use-results surveillance study of sovaldi® plus rebetol® in japanese patients with chronic genotype 2 hepatitis c virus infection

Conditions: Hepatitis C

Summary: this use-results post-marketing surveillance (pms) study for sovaldi® tablets (sofosbuvir, sof) administered in combination with rebetol® capsules (ribavirin, reb) will evaluate the safety and efficacy of sof administered in combination with ribavirin under real world use in japan. among adult patients with chronic genotype 2 hepatitis c virus (hcv) infection and treated with sof+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (adrs) under real world settings.


Eligibility criteria:
key inclusion criteria: * adult patients with serogroup 2 (genotype 2) chronic hcv infection with or without compensated cirrhosis * patients who are prescribed sof+reb key exclusion criteria: * none note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hepatitis c virus observational post-marketing sofosbuvir infection
repeat dose study of fluticasone propionate/salmeterol versus fluticasone propionate + salmeterol in asthmatics

Conditions: Asthma

Summary: a new formulation of fluticasone propionate/salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. administration occurred over 14 days and tolerability, pk (pharmacokinetic) and pd (pharmacodynamic) measurements were performed.


Eligibility criteria:
inclusion criteria: * documented history of mild or intermittent asthma * have pef and fev1\>80% predicted * not a smoker * bmi of 19 - 29 exclusion criteria: * have had a life threatening episode of asthma * have had a respiratory tract infection in the last four weeks * have other respiratory disease * have taken certain medications within restricted time periods

Keywords: asthma
gallium-68 nodaga-jr11 pect/ct in neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: nodaga-jr11 is a novel somatostatin receptor antagonist, while gallium-68 dotatate is a typical somatostatin receptor agonist. this study is to evaluate the lesion detection ability of gallium-68 nodaga-jr11 for the diagnostic imaging of metastatic, well-differentiated neuroendocrine tumors using positron emission tomography / computed tomography (pet/ct). the results will be compared between antagonist gallium-68 nodaga-jr11 and agonist gallium-68 dotatate in the same group of patients.

patients with histologically confirmed metastatic, well-differentiated neuroendocrine tumors will be recruited in this study. each patient received an intravenous injection of 68ga-dotatate (40ug/150-200mbq) on the first day and 68ga-nodaga-jr11 (40ug/150-200mbq) on the second day. whole-body pet/ct scans were performed at 40-60 min after injection on the same scanner. physiologic normal-organ uptake, lesion numbers, and lesion uptake were compared.

Eligibility criteria:
inclusion criteria: * • written informed consent. * patients of either gender, aged ≥ 18 years. * histologically confirmed diagnosis of metastatic, well-differentiated neuroendocrine tumor. * a diagnostic computed tomography (ct) or magnetic resonance imaging (mri) of the tumor region within the previous 6 months prior to dosing day is available. * at least 1 measurable lesion based on recist v1.1. * blood test results as follows (white blood cell: ≥ 3\*10\^9/l, hemoglobin: ≥ 8.0 g/dl, platelets: ≥ 50x10\^9/l, alanine aminotransferase / aspartate aminotransferase / alkaline phosphatase: ≤ 5 times upper limit od normal (uln), bilirubin: ≤ 3 times uln) * serum creatinine: within normal limits or \< 120 μmol/l for patients aged 60 years or older. * calculated glomerular filtration rate (gfr) ≥ 45 ml/min. exclusion criteria: * • known hypersensitivity to gallium-68, to nodaga, to jr11, to tate or to any of the excipients of gallium-68 nodaga-jr11 or gallium-68 dotatate. * presence of active infection at screening or history of serious infection within the previous 6 weeks. * therapeutic use of any somatostatin analog, including long-acting sandostatin (within 28 days) and short-acting sandostatin (within 2 days) prior to study imaging. if a patient is on long-acting sandostatina, then a wash-out phase of 28 days is required before the injection of the study drug. if a patient is on short-acting sandostatin, then a wash-out phase of 2 days is required before the injection of the study drug. * any neuroendocrine tumor-specific treatment between antagonist and agonist scans. * prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study. * pregnant or breast-feeding women. * current history of any malignancy other than neuroendocrine tumor; patients with a secondary tumor in remission of \> 5 years can be included. * any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
a hypnosis-based group intervention to improve quality of life in children with cancer and their parents.

Conditions: Pediatric Cancer

Summary: background: a lot of children with cancer suffer from emotional distress, fatigue and relational difficulties. their parents are also impacted by the disease: their responsibilities increase and they can feel more distressed and tired. different psychological interventions designed for ill children and their parents seem to be efficient to improve their social functioning, coping strategies and well-being. however, more research is needed in this field. hypnosis is often used in paediatric oncology, mostly to decrease procedure-related pain and distress. it has been used efficiently to improve the well-being of adults with cancer. this paper describes a pilot study designed to assess the feasibility and interest of a group intervention combining self-care and hypnosis for children with cancer and their parents, and a quasi-experimental protocol aimed at assessing the efficacy of this group intervention to improve the quality of life of children and their parents. methods: our pilot study showed that our intervention was feasible and positive for the participants. to test the efficacy of the intervention, two groups will be set up: one with children with cancer and their interested siblings, and one with their parents. data will be collected for each group before and after the intervention by questionnaires and a semi-structured interview. discussion: there is a growing interest in hypnosis in oncology settings. the results of this study should improve knowledge about the efficacy of a group intervention combining self-care and hypnosis to improve quality of life of children with cancer and their family.


Eligibility criteria:
inclusion criteria: * children and their siblings: * to be 8 to 18 year-old * to suffer from cancer (all localisations, stage and treatments accepted) or to have a sibling who suffer from cancer * to speak french * parents: * to have a child who suffer from cancer * to speak french exclusion criteria: * /
pediatric cardiac surgery comparing short 24-hour antibiotic prophylaxis to extended antibiotic prophylaxis

Conditions: Antibiotic Prophylaxis

Summary: the objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection. numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics. the study focuses on the incidence of postoperative infection by comparing antibiotic prophylaxis with 2nd generation cephalosporin (g2g) for 48 hours to a short antibiotic prophylaxis protocol limited to 24 hours. the bacterial infections considered were those said to be care-related, according to the criteria of the french society of anesthesia and intensive care if they occurred within the 3 months postoperative interval and were not present before the surgery: * sepsis * superficial or deep surgical site infection (mediastinitis, sternitis, scar infection) * catheterization infection, * urinary tract infection or * respiratory infection such as pneumopathy acquired under mechanical ventilation the hypothesis is that reducing the duration of antibiotic prophylaxis does not expose patients to an increased risk of infection and limits exposure to antibiotics


Eligibility criteria:
inclusion criteria: * child less than 18 years of age, * operated for cardiac surgery at the university hospital of strasbourg between january 2015 and june 2019, by sternal approach (sternotomy), * child and holders of parental authority who have not expressed, after information, their objections to the reuse of his for the purpose of this research. exclusion criteria: * child who has undergone thoracic heart surgery (thoracotomy), * child with an infection at the time of heart surgery, * child and parental authority holders who have expressed their objections to participating in this research

Keywords: antibiotic prophylaxis bacterial proliferation bacterial infections postoperative infection pediatric cardiac surgery
does the mesh have to be fixed in laparoscopic etep repair of inguinal hernia?

Conditions: Migration of Implant; Pain; Postoperative Complications; Relapse

Summary: inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. as with many open surgical methods, this repair is also performed laparoscopically. among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (etep). the benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate. one of the recent debates regarding the laparoscopic technique is mesh fixation. fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. however, it has been reported that this fixation may increase postoperative pain. several studies have reported that recurrence may be due to inadequate mesh fixation technique. in contrast, other prospective randomized studies have found relapse unrelated to mesh fixation. in the etep technique, dissection is performed in a larger area than in tep. for this reason, it can be thought that the possibility of mesh displacement is higher in the etep procedure. the purpose of this study is to confirm this idea with a prospective study. there are studies in the literature on mesh fixation related to the total extraperitoneal repair (tep) technique. however, there is no study on mesh detection in the etep technique. the aim of the study is to compare patients who underwent without mesh fixation laparoscopic tep and etep repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications.


Eligibility criteria:
inclusion criteria: * patients with unilateral inguinal hernias, * patients aged 18-65. exclusion criteria: * younger than 18 years, and older than 65 years, * incarcerated or strangulated inguinal hernias, * recurrent hernias, * patients with bilateral inguinal hernias, * patients who are contraindicated to receive general anesthesia, * pregnancy
bevacizumab in combination with verteporfin reduced and standard fluence in the treatment of hemorrhaged lesions in neovascular amd

Conditions: Macular Degeneration

Summary: the purpose of this study is to explore the combination of pdt with verteporfin at reduced and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal cnv of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage \>50% of total lesion area). to assess the safety of bevacizumab in combination with verteporfin pdt (reduced fluence: 300 mw/cm2) as compared to bevacizumab in combination with verteporfin pdt (standard fluence: 600 mw/cm2) in patients whose neovascular cnv lesions containing \>50% blood.

this is a phase one study in patients with all cnv lesion subtypes who are naïve to previous treatment. lesions must have blood as a primary component (i.e., contain more than 50% blood). patients will receive one of two combination treatments: * verteporfin pdt reduced fluence (300 mw/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection * verteporfin pdt standard fluence (600 mw/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection a total of 10 patients will be enrolled, 5 per treatment arm.

Eligibility criteria:
inclusion criteria: * patients are men or women of age 50 or older. * patients diagnosed with subfoveal cnv due to amd with lesion size ≤6 da. * patients have not received previous treatment for subfoveal cnv, in the study eye. * patients with visual acuities at baseline between 20/40 and 20/320, as evaluated on etdrs scale. * fluorescein angiography showing any type of subfoveal cnv at baseline with \>50% blood component of total lesion area. exclusion criteria: * patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light. * patients with history of glaucoma requiring treatment, or are currently on antihypertensive treatment for elevated intraocular pressure. * women of childbearing potential must not be pregnant of lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. * patients who have had treatment for cnv in the study eye with photodynamic therapy (pdt), transpupillary thermotherapy (ttt), or other local treatment (e.g. submacular surgery, intravitreal triamcinolone, intra-ocular antiangiogenic agents). previous laser photocoagulation therapy is acceptable, provided it was not subfoveal. * subject's currently who have been involved in any experimental procedure within the last 12 weeks.

Keywords: macular degeneration
sfx-01 after subarachnoid haemorrhage

Conditions: Subarachnoid Hemorrhage, Spontaneous

Summary: this is a safety, tolerability, pharmacokinetic and pharmacodynamic study of sfx-01 in subarachnoid haemorrhage, with exploratory evaluations of efficacy.

the study is a randomised, double-blind, parallel-group design comparing sfx-01 (300 mg) taken orally as capsules or as a suspension via a nasogastric tube (ng) twice-daily for up to 28 days versus placebo in 90 patients who have had sah and present within 48 hours of ictus. subjects will receive sfx-01/placebo in order to review potential outcomes investigating the long-term complications of sah such as delayed cerebral ischaemia, as reflected by trans-cranial doppler (tcd) readings. the objective is to demonstrate safety and search for signals of efficacy in patients that have had sah. a sub-study will be conducted in up to 12 patients where an external ventricular drain (evd) fitted; serial csf samples will be taken pre- \& post-dose on two occasions to determine pharmacokinetics of sulforaphane in csf in comparison with plasma pharmacokinetics. sub-study patients will undergo all other procedures (with the exception of lumbar puncture). treatment duration is up to 28 days; follow up duration is 28 days, three and six months. the planned trial period is 24 months.

Eligibility criteria:
inclusion criteria: 1. patients with radiological evidence of spontaneous sah 2. fisher grade 3 or 4 on ct 3. definitive treatment of aneurysm has not been ruled out 4. previously living independently 5. in the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours 6. aged 18 to 80 years 7. in the opinion of the investigator it will be possible to obtain informed consent from the patient, personal legal representative or professional legal representative within 24 hours of first dose exclusion criteria: 1. traumatic sah 2. fisher grade 1 or 2 3. sah diagnosed on lumbar puncture with no evidence of blood on ct 4. decision not to treat aneurysm has been made 5. plan to withdraw treatment 6. significant kidney disease as defined as plasma creatinine ≥2.5mg/dl (221 µmol/l) 7. liver disease as defined as total bilirubin ≥2-fold the upper limit of normal; (uln) as measured by the local laboratory 8. females who are pregnant or lactating. 9. participants enrolled in another interventional research trial in the last 30 days 10. patients for whom it is known, at the time of screening, that clinical follow-up will not be feasible patients unwilling to use two forms of contraception (one of which being a barrier method) 30 days for men and 90 days for women after last imp dose
comparison of physical and psychosocial characteristics of pectus excavatum and carinatum patients with healthy controls

Conditions: Pectus Deformity; Physical Disability; Psychosocial Impairment

Summary: chest wall deformities are the development of ribs, cartilage and sternum that form the chest wall together with isolated or abnormalities of the musculoskeletal system. pectus excavatum and carinatum deformities are most common. it is reported that individuals with this problem have posture and physical impairments, difficulty in psychosocial relations and decreased quality of life.therefore, in this study, the investigators aimed to evaluated the physical and psychosocial characteristics of patients with pectus excavatum and carinatum compared with healthy controls.

pectus excavatum (pe) and pectus carinatum (pc) are the most common anterior chest-wall deformities. both of these malformations predominantly affect males. they often coincide with the vulnerable life phase of puberty, a period characterized by great physical, social, and emotional changes. outer appearance becomes a major issue for adolescents, and those who display a visible disfigurement may be put at a disadvantage, having to come to terms with a difference in their looks and having to face the risk of harassment by their peers. patients with pectus deformities often experience feelings of shame and try to hide their chests. this can be reflected in the choice of clothing or poor body posture. many patients even avoid social activities and sports. they are aware of the fact that their deformity is generally not considered attractive, and some regard it as an obstacle in future relationships. reduced self-confidence and selfesteem appear to be rather common characteristics of pe patients. recently, several authors have assessed the improvement of quality of life and body image following surgical repair of pe. yet, little is known about the degree to which patients, differ from healthy individuals within the same age group. steinmann et al observed reduced disease-specific and general health related quality in patients with a chest malformation. body image was highly impaired in both pe and pc patients. however, the number of patients (71 pe, 19, pc, 82 healthy individuals) was not matched and was not evaluated physical function. also, they evaluated patients with a high degree of preoperative deformity in this study. therefore, the investigators aimed to evaluated the physical and psychosocial characteristics of patients with pectus excavatum and carinatum compared with healthy controls.

Eligibility criteria:
inclusion criteria: * diagnosis of chest wall deformity by doctor * not having any chronic systemic and musculoskeletal diseases and injuries for healthy individuals exclusion criteria: * having chronic systemic disease * genetic disease * being psychologically diagnosed * having additional musculoskeletal diseases

Keywords: pectus carinatum pectus excavatum physical impairment psychosocial impairment
study of the expression of mmps in ome in children with atrophy of the eardrum

Conditions: Otitis Media With Effusion

Summary: metalloproteinases (mmps) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. activity of mmp has been shown in some otitis media with effusion (ome) fluids. these enzymes could be directly linked to the prosnostic of ome as it may damage the eardrum and leads to tympanic atrophy. the main goal of the study is to find out the correlation between activity of mmps and tympanic atrophy. the investigator will also study if there is any clinical predictive factors in relation to the level of mmps.

the investigator will include 35 children under 12 years old with ome and who need tympanostomy or tube placement under general anesthesia. middle ear effusion will be collected, divided in two and frozen. the investigator will perform elisa tests to measure the level of mmp2 mmp9 mmp7 et timp2 (inhibitor of mmps). the investigator want to compare the level of mmps between healthy eardrum and atrophic membrane. clinical data will be collected such as age, gender, chronicity of the ome, quality of the eardrum and middle ear effusion type to see if there is any difference when mmps level is higher.

Eligibility criteria:
inclusion criteria: - every children under 12 yo operated on in gui de chauliac hospital exclusion criteria: - when effusion is not possible to collect (too thick or amount of fluid not enough) collection of both mee on each ear when ome is bilateral. we will perform the tests on only one ear. the other one will be kept in case of technical issue. a random draw will establish which ear will be tested.